If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Ingenol Mebutate Gel 0.05% Decreases Actinic Keratosis Lesions: Presented at AAD By Perrie Susman MIAMI BEACH, Fla -- March 7, 2010 -- Two-day therapy with ingenol mebutate gel 0.05%, also known as PEP005, is extremely effective in decreasing actinic keratosis lesions, according to phase 3 results presented here at the 68th Annual Meeting of the American Academy of Dermatology (AAD). Neil Swanson, MD, Dermatology Division, Oregon Health & Sciences University, Portland, Oregon, presented findings in 255 patients randomised to receive either the investigational ingenol mebutate gel 0.05%, applied topically as monotherapy for body actinic keratosis lesions once daily for 2 consecutive days, or vehicle. The primary efficacy endpoint was complete clearance. Complete clearance of actinic keratosis lesions across all nonanatomical, nonhead sites at day 57 was documented in 32 (27.4%) patients with ingenol mebutate versus 6 (5.1%) patients in the vehicle group (P = .0001). The complete clearance rates for the active treatment were 88.9% (8 of 9) for chest, 25.3% (19 of 75) for arms, 16.7% (1/6) for legs, 16.0% (4 of 25) for back of the hand, and 0% (0 of 2) for back. Partial clearance, a secondary endpoint, was seen in 52 (44.4%) patients in the active-treatment group versus 9 (7.6%) in the vehicle group (P < .0001). “Cryotherapy has been the gold standard for actinic keratosis for some time, with topical agents also used over a period of weeks to months. Findings from this study suggest that PEP005, a topical gel administered over just 2 days, may provide a safe and effective alternative to current therapies,” said Dr. Swanson on March 6. The investigators also noted a 66.7% median reduction and a 0% median reduction in actinic keratosis lesion count from baseline across all anatomical nonhead sites in the 2 treatment groups, respectively. Adverse events, primarily application-site irritation and pruritus, were typically mild and resolved by day 57. Overall, 7 patients in the ingenol mebutate group had pigmentation changes, with 4 reporting improvement of pigmentation and 3 reporting worsening of pigmentation. No patient had a worsening in scarring. “There were no drug-related serious adverse events, and 98% of patients applied both doses,” Dr. Swanson said. Funding for this study was provided by LEO Pharma. [Presentation Title: Multicenter, Randomized, Parallel-Group, Double-Blind Vehicle-Controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel 0.05% in Patients With Actinic Keratoses (AK) on Non-head Locations. Abstract P105]
|
